Phase
Condition
Psoriatic Arthritis
Joint Injuries
Treatment
Golimumab
Guselkumab
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6months prior to the first administration of study intervention and meetClassification criteria for PsA (CASPAR) criteria at screening
Have active PsA as defined by having at least 3 swollen joints and at least 3 tenderjoints at screening and at baseline
Have at least 1 of the following PsA subsets: distal interphalangeal jointinvolvement, polyarticular arthritis with absence of rheumatoid nodules, arthritismutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis, with at least one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis
Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment witheither 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit toeither 1 or 2 prior anti-TNF-alpha therapies, as documented in the participanthistory by the treating physician, after at least 12 weeks of etanercept,adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, orany biosimilar of these 4 therapies. Documented lack of benefit may includeinadequate improvement in joint counts, physical function, or disease activity; b.The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-livesof the drug prior to first study intervention administration (washout period)
Exclusion
Exclusion Criteria:
Has other inflammatory diseases that might confound the evaluations of benefit ofguselkumab and/or golimumab therapy, including but not limited to rheumatoidarthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease
Has known intolerance or hypersensitivity to any biologic medication, or knownallergies or clinically significant reactions to murine, chimeric, or humanproteins, monoclonal antibodies (mAb), or antibody fragments
Has received prior treatment with golimumab or guselkumab or has documentedintolerance to prior anti-TNF-alpha therapy in the participant history by thetreating physician
Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)
Positive human immunodeficiency virus (HIV) antibody test
Study Design
Study Description
Connect with a study center
Frederiksberg Hospital
Frederiksberg, 2000
DenmarkSite Not Available
Rigshospitalet Glostrup
Glostrup, 2600
DenmarkSite Not Available
Køge Sygehus Region Sjaelland
Køge, 4600
DenmarkSite Not Available
Silkeborg Hospital
Silkeborg, 8600
DenmarkSite Not Available
Vejle Sygehus
Vejle, 7100
DenmarkSite Not Available
Centre Hospitalier Le Mans
Le Mans, 72037
FranceSite Not Available
Hospital Center Regional D'orleans Hospital La Source
Orleans cedex 2, 45067
FranceSite Not Available
Hopital Larrey CHU de Toulouse
Toulouse Cedex 9, 31059
FranceSite Not Available
CHU Trousseau - Service de Rhumatologie
Tours, 37044
FranceSite Not Available
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
HungarySite Not Available
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036
HungarySite Not Available
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
HungarySite Not Available
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
HungarySite Not Available
Complex Rendelo Med Zrt
Szekesfehervar, 8000
HungarySite Not Available
Complex Rendelo Med Zrt
Székesfehérvár, 8000
HungarySite Not Available
Vital Medical Center
Veszprem, 8200
HungarySite Not Available
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprem, 8200
HungarySite Not Available
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, 09124
ItalySite Not Available
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milano, 20122
ItalySite Not Available
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano, 20122
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, 80138
ItalySite Not Available
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, 27100
ItalySite Not Available
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
ItalySite Not Available
A.O.U.Policlinico Tor Vergata
Roma, 00133
ItalySite Not Available
Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Università Campus Biomedico di Roma
Rome, 00128
ItalySite Not Available
AO Ordine Mauriziano
Torino, 10128
ItalySite Not Available
Ospedale Mauriziano (Torino)
Torino, 10128
ItalySite Not Available
Centrum Kliniczno Badawcze
Elblag, 82 300
PolandSite Not Available
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-242
PolandSite Not Available
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-242
PolandSite Not Available
NZOZ Lecznica MAK MED S C
Nadarzyn, 05 830
PolandSite Not Available
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, 05-830
PolandSite Not Available
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sol, 67-100
PolandSite Not Available
Centrum Medyczne
Poznan, 61 113
PolandSite Not Available
Medycyna Kliniczna
Warsaw, 00-874
PolandSite Not Available
Centrum Medyczne AMED Targowek
Warszawa, 03 291
PolandSite Not Available
Centrum Medyczne AMED Warszawa Targowek
Warszawa, 03-291
PolandCompleted
Centrum Medyczne FutureMeds Targowek
Warszawa, 03-291
PolandCompleted
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, 51 685
PolandSite Not Available
WroMedica I.Bielicka, A.Strzalkowska s.c.
Wrocław, 51-685
PolandSite Not Available
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław, 51-685
PolandSite Not Available
Chelyabinck Regional Clinical Hospital
Chelyabinsk, 454076
Russian FederationSite Not Available
Kemerovo State Medical University
Kemerovo, 650000
Russian FederationSite Not Available
LLL Medical Center Revma-Med
Kemerovo, 650070
Russian FederationSite Not Available
LLC Family Outpatient Clinic # 4
Korolev, 141060
Russian FederationSite Not Available
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar, 350020
Russian FederationSite Not Available
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow, 129110
Russian FederationSite Not Available
Orenburg State Medical Academy
Orenburg, 460000
Russian FederationSite Not Available
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, 344007
Russian FederationSite Not Available
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, 390046
Russian FederationSite Not Available
Smolensk regional hospital on Smolensk railway station
Smolensk, 214025
Russian FederationSite Not Available
Medical Center Uninova Llc
St-Petersburg, 194156
Russian FederationSite Not Available
X7 Clinical Research Company Limited
St. Petersburg, 194156
Russian FederationSite Not Available
Tula Regional Clinical Dermatovenerological Dispensary
Tula, 300053
Russian FederationSite Not Available
Republican Clinical Hospital - G.G. Kuvatov
Ufa, 450005
Russian FederationSite Not Available
Clinical Hospital #3
Yaroslavl, 150007
Russian FederationSite Not Available
Hosp Univ A Coruna
A Coruna, 15006
SpainSite Not Available
Hosp. Univ. A Coruna
A Coruna, 15006
SpainSite Not Available
Hosp. Univ. A Coruna
A Coruña, 15006
SpainSite Not Available
Hosp. Univ. A Coruña
A Coruña, 15006
SpainActive - Recruiting
Hosp. Univ. Germans Trias I Pujol
Barcelona, 08916
SpainSite Not Available
Hosp. Univ. de Basurto
Bilbao, 48013
SpainSite Not Available
Hosp Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hosp. Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hosp. Reina Sofia
Córdoba, 14004
SpainSite Not Available
Hosp. Univ. 12 De Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hosp. Infanta Luisa
Sevilla, 41010
SpainSite Not Available
Hosp. Ntra. Sra. de Valme
Sevilla, 41014
SpainSite Not Available
Hosp. Virgen Macarena
Sevilla, 41009
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainSite Not Available
Linkoping University Hospital
Linkoping, 581 85
SwedenSite Not Available
Skanes universitetssjukhus
Malmo, 205 02
SwedenSite Not Available
Karolinska Universitetssjukhuset Solna
Solna, 171 76
SwedenSite Not Available
Akademiskt Specialistcentrum centrum för reumatologi
Stockholm, 113 65
SwedenSite Not Available
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, 61204
UkraineSite Not Available
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, 61039
UkraineSite Not Available
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv, 03049
UkraineSite Not Available
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv, 03037
UkraineSite Not Available
Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
Kyiv, 04107
UkraineSite Not Available
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, 03680
UkraineSite Not Available
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava, 36011
UkraineSite Not Available
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, 46002
UkraineSite Not Available
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhgorod, 88000
UkraineSite Not Available
Health Clinic Limited Liability Company
Vinnytsia, 21009
UkraineSite Not Available
Medical Center LLC 'Modern Clinic'
Zaporizhzhya, 69600
UkraineSite Not Available
Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona 85037
United StatesSite Not Available
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona 85037
United StatesSite Not Available
Unity Health-White County Medical Center
Searcy, Arkansas 72143
United StatesSite Not Available
HARAC Research Corp
Avon Park, Florida 33825
United StatesSite Not Available
Bay Pines VA Healthcare System
Bay Pines, Florida 33744
United StatesSite Not Available
Omega Research Consultants
DeBary, Florida 32713
United StatesSite Not Available
Sweet Hope Research Specialty, Inc.
Hialeah, Florida 33016
United StatesSite Not Available
South Coast Research Center
Miami, Florida 33136
United StatesSite Not Available
Advanced Clinical Research of Orlando
Ocoee, Florida 34761
United StatesSite Not Available
Millennium Research
Ormond Beach, Florida 32174
United StatesSite Not Available
Atlanta Research Center for Rheumatology
Marietta, Georgia 30060
United StatesSite Not Available
Great Lakes Center of Rheumatology
Lansing, Michigan 48911
United StatesSite Not Available
Clinvest
Springfield, Missouri 65807
United StatesSite Not Available
Excel Clinical Research
Las Vegas, Nevada 89109
United StatesSite Not Available
Jacobi Medical Center
Bronx, New York 10461
United StatesSite Not Available
NYC Health & Hospitals
Bronx, New York 10451
United StatesSite Not Available
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York 11201
United StatesSite Not Available
NYU School of Medicine
New York, New York 10016
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
STAT Research, Inc.
Vandalia, Ohio 45377
United StatesSite Not Available
VA North Texas Health Care System
Dallas, Texas 75216
United StatesSite Not Available
West Texas Clinical Research
Lubbock, Texas 79410
United StatesSite Not Available
Trinity Universal Research Associates, LLC
Plano, Texas 75024
United StatesSite Not Available
Epic Medical Research
Red Oak, Texas 75154
United StatesSite Not Available
Advanced Rheumatology of Houston
The Woodlands, Texas 77382
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesSite Not Available
Center of Rheumatic Diseases
Glendale, Wisconsin 53217
United StatesSite Not Available
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